Gottlieb unveils sweeping plan to revamp DSHEA, review botanical safety, recharge NDI process

By Hank Schultz

- Last updated on GMT

Gottlieb unveils sweeping plan to revamp DSHEA, review botanical safety, recharge NDI process
FDA will inaugurate a public dialogue process this spring to discuss possible changes to DSHEA, take a fresh look at botanical product safety and to reinvigorate the NDI process. The plan was laid out in a statement from FDA Commissioner Dr Scott Gottlieb, MD, released this morning.

Gottlieb laid out a six step plan to reorganize the way the agency regulates supplements and responds to public health issues. Primary among these changes is to engage with industry in figuring out ways in which the industry’s overarching legislation, DSHEA (Dietary Supplement Health and Education Act) can be “modernized.” The statement builds on a speech that Gottlieb gave back in December​.

DSHEA do over

DSHEA is approaching its 25th anniversary. Many stakeholders in the dietary supplement industry have resisted for years any suggestion that the law could be amended to better reflect market conditions as they stand today as opposed to what they were in 1994. The idea had been that to open up the amendment process would provide an opportunity for opponents of the industry to change the law in a way that could prove damaging to the industry.

But in the past four or five years, consensus has been building that it’s time for a reworking of DSHEA. A law created for a market of 5,000 or so products is being stretched now to accommodate a marketplace that is at least 10 times bigger. And it’s a marketplace that new companies can enter with remarkable ease.

In his statement,​ Gottlieb said possible changes to DSHEA would be hashed in what he termed a “public dialogue.”

“We’ve heard from stakeholders who want to open such a dialogue. While the FDA is committed to leveraging its existing resources and authorities to the fullest extent possible, we believe there may be value in a broader public conversation about whether certain changes to the law might be helpful,”​ Gottlieb said.

“We believe there may be opportunities to modernize DSHEA for the future, while preserving the law’s essential balance. For example, some stakeholders have suggested that the statute should be amended to establish avenues for dietary supplement exclusivity and add a product listing requirement. A mandatory listing requirement could provide significant benefits by facilitating efficient enforcement of the law and establishing new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry,” ​he added.

Rapid response

Gottlieb also said the agency plans to develop a “rapid response tool” that will enable the agency to more quickly warn consumers to avoid products on the market with illegal and potentially dangerous ingredients. He also signaled an intent to continue to fine tune FDA’s enforcement strategies. As an example, he alluded to the 12 warning letters and four online advisories that the agency also made public today​.

Botanical group

Gottlieb also revealed the Botanical Safety Consortium, which was convened late last year delve into the issues surrounding these products.

“In essence, the BSC is a public-private partnership with the goal to provide appropriate tools to evaluate the safety of botanical ingredients. We aim to have validated in vitro assays for the safety evaluation of these ingredients. There are many published papers on the potential toxicity of botanical ingredients, but often, such results from in vitro or animal studies turn out to be of no clinical relevance. I believe we have an opportunity to provide better, and more predictive tools to evaluate botanical ingredients, and to show that these ingredients can be used safely,”​ said Stefan Gafner, chief science officer of the American Botanical Council, who is participating in the effort.

Gafner said the BSC is led by a steering committee and will include subgroups that will work on chemical characterization (analytical subgroup), hepatotoxicity, genotoxicity, reproductive and developmental toxicity, cardiotoxicity, and systems toxicity.

NDI question

As to how the NDI Draft Guidance might be modified, Gottlieb said a meeting with industry stakeholders will be held this spring. The goal is to provide incentives for companies to participate in the process.  Among the carrots that might be proffered would be some form of IP protection, which is seen as a weak link in the way the notification process works at the moment.   Another sticking point with the current guidance has been the narrow view of what qualifies as a legal dietary ingredient (synthetic versions of botanical ingredients don’t, under FDA’s current view, for example).

“We’ll look to address other challenges that may act as barriers to dietary supplement innovation and safety including issues such as what the right incentives might be for establishing dietary supplement exclusivity, and the scope of permitted dietary ingredients,” ​Gottlieb said.

Industry’s take

Industry stakeholders generally looked favorably on Gottlieb’s proposals.

“CRN appreciates the commitment of FDA Commissioner Dr. Scott Gottlieb to strengthen the dietary supplement industry and to modernize FDA’s oversight of these products. He clearly shares our respect, both as a doctor and as a consumer, for the power of dietary supplements to improve the lives and health of all Americans, three-quarters of whom already take our products each year,” ​said Steve Mister, president and CEO of the Council for Responsible Nutrition.

“Having a discussion about what people want to do in the future is great but I think that should not stop FDA from using the authorities it now has to appropriately regulate the market. If we take CBDs as one example, the market has proliferated to about 1,400 products in just three years. FDA says one thing and then does something else. There are current issues that FDA should be addressing that it seems to turn a blind eye to,”​ said Daniel Fabricant, PhD, president and CEO of the Natural Products Association.

The full text of Dr Gottlieb's statement can be read here​.

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